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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Expert Roundtable
Spotlight Article

Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

Raw and Starting Materials

Richard McFarland, ARMI (Advanced Regenerative Manufacturing Institute) Ivar Kljavin, Thermo Fisher Scientific & Timothy Moore,Kite, a Gilead Company

Richard McFarland, Chief Regulatory Officer, ARMI (Advanced Regenerative Manufacturing Institute)

Richard McFarland, PhD, MD, joined ARMI as its Chief Regulatory Officer in May 2018 having been at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).

Ivar Kljavin , Head of Quality, Bioproduction Division at Thermo Fisher Scientific

Ivar joined Thermo Fisher in January 2018 having spent 24 years in the pharmaceutical industry with Roche – five years in research and the rest in Global Quality roles, QC/QA. What drew him to the Thermo Fisher role is the opportunity to influence the future state of supply of medicine to patients. Ivar is passionate about the transition of Thermo Fisher’s quality system – and the need to integrate Quality process and goals with customers so that we are aligned with the mission of insuring supply of medicine to patients. Thermo Fisher definitely has the capability to make this happen.

Timothy Moore, Executive Vice President, Technical Operations, Kite, a Gilead Company

Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of the Executive Committee of BioPhorum Operations Group (BPOG) and the Manufacturing Leadership Council. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

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